The Recall Desk
HighFDA (Devices)·Z-0912-2022·Announced 2022-04-20

Orthopedic surgical hammertoe instrument recalled for improper component sizing

Nextremity Solutions is recalling the Nextra Hammertoe Correction System due to an oversized driver component that makes it difficult to properly connect and remove during surgery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II device recall with no reported injuries or hospitalizations. This represents a risk-of-harm product where the manufacturing defect could impair surgical effectiveness, but no actual harm has been documented.

Plain-English summary

The Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit (SKU: NX-3532K), manufactured by Nextremity Solutions, is being recalled by the FDA due to a manufacturing defect affecting the proximal end of the driver.

The driver component is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant. This defect can cause delays during surgical procedures.

The recalled product was distributed in the United States, Japan, and the Netherlands. A total of 285 units were affected (Lot Number: 168125017A, UDI: 00817701020042).

The recalled product

Product
Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument
Manufacturer
Nextremity Solutions
Category
Medical Device — Orthopedic Surgical Instrument
Hazard
  • oversized-component
  • connection-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: 168125017A UDI: 00817701020042

Distribution

Distributed nationwide across the United States.

Related recalls

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